典型文献
Clinical review considerations of class Ⅰ PI3K inhibitors in hematolymphatic malignancies by Center for Drug Evaluation
文献摘要：
Several phosphoinositide 3-kinase(PI3K)inhibitors are currently approved to treat hematolymphatic malignant diseases worldwide,and many drugs that have the same target are in the clinical research stage.In March 2022,duvelisib became the first PI3K inhibitor approved in China indicated for the treatment of hematolymphatic malignant diseases.Meanwhile,linperlisib and copanlisib have almost completed the technical review of the clinical specialty.The Center for Drug Evaluation(CDE)of the China National Medical Products Administration(NMPA)found that class Ⅰ PI3K inhibitors can cause various degrees of immune-related adverse events,which are associated with action mechanisms,affecting the benefit-risk assessment of the drugs.On April 21,2021,the United States Food and Drug Administration(FDA)convened the Oncologic Drugs Advisory Committee(ODAC)meeting to discuss the safety of PI3K inhibitors indicated for hematolymphatic malignancies and their related risk of death.The hematological tumor group of CDE of the China NMPA summarized and combined the data on PI3K inhibitors listed or under technical review for marketing authorization applications and found that such products may have unique efficacy and safety characteristics in Chinese patients with malignant lymphoma.
文献关键词：
中图分类号：
作者姓名：
Limin Zou;Yueli Qi;Ling Tang;Yu Du;Meiyi Xiang;Xiaoming Chen;Jun Ma;Zhimin Yang
作者机构：
Office of Clinical Evaluation 1,Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China;Office of Management and Communication,Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China;Harbin Institute of Hematology and Oncology,Harbin 150010,China
文献出处：
引用格式：
[1]Limin Zou;Yueli Qi;Ling Tang;Yu Du;Meiyi Xiang;Xiaoming Chen;Jun Ma;Zhimin Yang-.Clinical review considerations of class Ⅰ PI3K inhibitors in hematolymphatic malignancies by Center for Drug Evaluation)[J].中国癌症研究（英文版）,2022(04):415-421
A类：
hematolymphatic,duvelisib,linperlisib,copanlisib,Oncologic,ODAC
B类：
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AB值：
0.542006
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